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ORTHOMEDFLEX LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104914463010491446ORTHOMEDFLEX LLC1Y2020-04-251104 Spruce Street Belmont NC US 28012

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M7161011020OrthoMedFlex - Straight Broach Handle - 135 Degrees1-844-663-3539info@orthomedflex.com
M7161011250OrthoMedFlex - Quick Release Head Impactor8446633539info@orthomedflex.com
M7161011260OrthoMedFlex - Quick Release Stem Impactor8446633539info@orthomedflex.com
M7161011340OrthoMedFlex - Stem Positioner8446633539info@orthomedflex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1714941384612870K161155Origin Coxa Vara Hip StemMEH2016-07-19
1714941507998440K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerMEH2016-06-03
1714941092727434K133370REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CELPH2014-07-22
1714941008639553K121297ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARLPH2012-12-28
1714941930110184K101451APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEADLZO2010-06-22
1714941001134516
1714941018275259
1714941130508752
1714941139970542
1714941204352706
1714941274012150
1714941294737854
1714941444580049
1714941467977644
1714941665798517
1714941666247240
1714941684807752
1714941826316523
1714941999481040
1714942039007666
1714942058662656

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MEH22016-07-19
LPH22014-07-22
LZO12010-06-22

GUDID#

200 records. Showing 1-40. Next